Pharma major Ranbaxy Laboratories Ltd has received approval from the USFDA for manufacturing and marketing cholesterol-lowering Simvastatin Tablets in the US market.
The company said it has received the approval for marketing the drug in strengths of 80mg with 180 day exclusivity.
Simvastatin, currently marketed as 'Zocor' in the US, has been found to be bioequivalent by the FDA Office of Generic Drugs. The total annualized market sales for Simvastatin is 4.6 billion dollars, out of which the 80mg strength accounts for 513 million dollars.
"We anticipate significant benefits and value from our Simvastatin formulation to both patients and prescribers," Ranbaxy CEO and Managing Director Malvinder Mohan Singh said.
The drug is indicated in the treatment of patients with coronary heart disease, hypercholesterolemia requiring modifications of lipid profiles and adolescent patients with Heterozygous Familial Hypercholesterolemia (HeFH).
"We expect to launch Simvastatin 80mg on an exclusive basis immediately. We believe that by offering an affordably priced generic alternative, we will have a positive impact on the cost of healthcare for patients who have or are at high risk of coronary heart disease," Ranbaxy Pharmaceuticals Inc Vice President of sales and marketing Jim Meehan said.